rft5-dga immunotoxin in treating patients with relapsed or refractory cutaneous t-cell non-hodgkin lymphoma

Conditions: Lymphoma

Summary: rationale: immunotoxins, such as rft5-dga immunotoxin (also called anti-cd25 immunotoxin imtox25), can find certain cancer cells and kill them without harming normal cells. purpose: this phase ii trial is studying the side effects of anti-cd25 immunotoxin imtox25 and how well it works in treating patients with relapsed or refractory cutaneous t-cell non-hodgkin lymphoma.

objectives: primary * determine the response rate of patients with relapsed or refractory cutaneous t-cell non-hodgkin lymphoma (ctcl) following treatment with rft5-dga immunotoxin (anti-cd25 immunotoxin imtox25) . secondary * determine whether responses correlate with the level of cd25+ expression on the ctcl tumor cells. * determine whether changes in the pre-treatment and the post-treatment levels of cd4+cd25+ treg cells correlate with responses. outline: patients receive anti-cd25 immunotoxin imtox25 iv over 4 hours on days 1, 3, and 5. treatment repeats every 6 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. tissue and blood samples are collected at baseline, and during study for cd25+ expression by fluorescent-activated cell sorter analysis, immunohistochemistry. after completion of study therapy, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed cutaneous t-cell non-hodgkin lymphoma (ctcl) * relapsed or refractory disease, meeting 1 of the following criteria: * progression of disease following 2 prior chemotherapies * failure to respond to the second prior chemotherapy * measurable disease patient characteristics: * ecog performance status 0-2 * life expectancy \> 3 months * serum creatinine \< 1.5 times upper limit of normal (uln) * serum ast/alt \< 2.5 times uln * total bilirubin ≤ 2.0 mg/dl (\< 3.0 mg/dl in patients with gilbert syndrome) * wbc count ≥ 3,000/mm³ * platelet count ≥ 100,000/mm³ * serum albumin \> 2.5 g/dl * lvef ≥ 45% by 2-d echo or muga scan * human antimurine antibody \< 1 μg/ml * patients with a history of electrocardiogram abnormalities, symptoms of cardiac ischemia, or arrhythmias must have a normal cardiac stress test (i.e., stress thallium, stress muga, dobutamine echocardiogram, or other stress test) * must be willing to undergo venipuncture and central line placement * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no hbv surface antigen, hcv, or hiv antibody positivity * no autoimmune disease or immunodeficiency (i.e., hiv) * no history of uncontrolled concurrent illness including, but not limited to, any of the following: * ongoing or active infection * ongoing or active cardiac disease (i.e., congestive heart failure, unstable angina pectoris, or cardiac arrhythmia) * psychiatric illness and/or social situation that would preclude study compliance * no other malignancies except treated basal cell or squamous cell carcinoma of the skin, or treated carcinoma in situ of the cervix prior concurrent therapy: * see disease characteristics * more than 3 weeks since prior systemic therapy for ctcl * more than 6 months since prior chronic steroid therapy or chronic anti-coagulation therapy * no prior therapy with anti-cd25 immunotoxin imtox25 and/or ontak * no other concurrent cancer chemotherapy, experimental therapy, investigational agent, or immunomodulating agent (including steroids)

Keywords: recurrent mycosis fungoides/sezary syndrome recurrent cutaneous t-cell non-hodgkin lymphoma